Category: Breaking News

A U.S. Food and Drug Administration (FDA) advisory panel voted unanimously Friday to recommend Pfizer (PFE)/BioNTech’s (BNTX) third dose for Americans 65 and older, and for those with high risk of contracting a severe case of COVID-19. The vote authorizing a booster for 65 and older was the panel’s second decision of the afternoon, following a ruling against booster doses for Americans 16 and over. The second vote also approved emergency use authorization rather than a supplemental approval of the already fully-licensed vaccine. A CDC advisory panel meeting, slated for next week, will delve further into who will qualify for the additional dose. Dr. Lena Wen, visiting professor at George Washington University Milken Institute School of Public Health, told Yahoo Finance the vote achieved a balance. The vote comes after a heated debate in recent weeks over the need for booster or additional shots, which both mRNA companies — Pfizer and Moderna (MRNA) — have advocated for. “This is a reasonable ‘middle ground’ solution and gives discretion to physicians and patients to decide who is high risk. That level of individual decision-making is key,” Wen said. “Of course, it’s true that the unvaccinated are the major problem when it comes to spread of covid, but it shouldn’t mean that those vaccinated don’t deserve to be better protected with an extra dose if they so choose,” Wen added. Dr. Peter Marks, the FDA’s leading expert on vaccines, touched on the recent controversy in his introductory remarks. “We know that there may be differing opinions of the interpretation of the data regarding the potential need for additional doses, and we strongly encourage all the different viewpoints to be voiced and discussed regarding the data, which is complex, and evolving,” Marks said. He added the meeting focused on almost real-time analyses compared to what is happening in the world, and the goal remains slowing the spread of COVID-19, which is killing almost 2,000 Americans daily. The question the advisory panel was originally given to consider only used the U.S. data, a small dataset, despite the presentations including data from the U.K. and Israel. Marks instructed the panel to consider all the data, noting, “This is not a legal proceeding, this is a science proceeding, so you can take all the data into account.” The meeting precedes a September 20 start date for additional doses, announced last month by the White House COVID-19 Response Team, despite U.S. Centers for Disease Control and Prevention (CDC) data showing some Americans are already receiving third doses. Last month, the CDC recommended additional doses for immunocompromised people. A CDC advisory panel will meet next week to discuss recommendations for who should receive a booster dose. At a Response Team briefing Friday, U.S. Surgeon General Dr. Vivek Murthy said the administration is already communicating with pharmacies, nursing homes and state officials to help roll out additional doses. But whether or not the average American also needed boosters had been a growing debate for weeks. Measuring antibody levels after a vaccine, which tend to wane, versus relying on memory cells, which can recall how to fight the virus, as is typical in vaccinations, was at the heart of the debate in the science community. A Pfizer official acknowledged that “its a much more complex story” than just antibody titers — even as the company relied on that data to advocate for additional doses. Meanwhile, some who opposed third doses believed those doses could be better used in countries with low vaccination rates. Marks also addressed that at the start of the meeting Friday, noting that the committee is only supposed to weigh on the data and need for shots, and not on global vaccine equity or operational concerns in rolling out a booster campaign in the U.S. The decision Friday heavily leaned on data from Israel, as well as the U.K., which has been a point of concern. In days prior, both mRNA vaccine companies discussed and advocated for boosters. A new report from the CDC Friday showed that Moderna’s vaccine remained stronger in protecting against hospitalization compared to Pfizer and Johnson & Johnson (JNJ). Both mRNA company CEOs have previously told Yahoo Finance that additional doses are inevitable. But when those doses will be needed — annually or sometime after a third shot — remains unknown. Moderna president Stephen Hoge said as much in a recent interview. “We don’t really know” if a third shot will be the final or if more are needed, he said. Pfizer CEO Albert Bourla penned an open letter advocating for boosters based on the company’s clinical trial data and data from Israel. But the FDA previously cautioned that some studies from Israel, including a few published this week, have not been independently verified by the regulatory agency. Bourla also addressed the concerns about equitable distribution of vaccines globally. “I believe …that the introduction of booster doses should not change the number of doses that each country receives. No commitments already made by Pfizer to a country will change if boosters are approved,” Bourla said. Meanwhile, the U.S. is reportedly gearing up to buy an additional 500 million doses of the Pfizer vaccine for global donations, according to the Washington Post.

SCIENTISTS have raised new concerns about the rapid spread of the Delta variant of coronavirus, warning new restrictions “may still be required” even after a successful vaccine rollout. The Covid warning comes after the Government did not rule out a “firebreak” lockdown in response to rising infections and hospitalisations with COVID-19, but only as “a last resort” measure. The Delta variant was first reported in India last year and has quickly proven to be more easily transmissible and resistant to Covid antibodies. The SARS-CoV-2 B.1.617.2 variant has since spread to more than 90 countries and has emerged as the leading cause of infections in the UK, US and Israel, among others.

LONDON (Reuters) – England launched its COVID-19 booster vaccination campaign on Thursday, the National Health Service (NHS) said, after officials and the government gave the go-ahead for the programme earlier in the week. British Prime Minister Boris Johnson on Tuesday outlined how the booster programme for over-50s and other priority groups will form a key plank of his plan to navigate the winter without further coronavirus lockdowns. Booster vaccinations will be given at least six months after people received their second dose of COVID-19 vaccine, meaning the rollout will roughly follow the original priority list, and start with the oldest, most vulnerable and health workers. NHS England said that hospital hubs had started vaccinating health workers, with full rollout to the community set to begin next week. “It is brilliant to see that the first booster jabs are being rolled out today,” health minister Sajid Javid said. “I urge everyone who is eligible to come forward for their booster when invited, to prolong the protection that the vaccine offers those most at risk as we approach the winter months.” Britain’s Joint Committee on Vaccination and Immunisation (JCVI) recommended that Pfizer/BioNTech’s shot be used in the booster campaign, or alternatively a half-dose of Moderna’s vaccine. The government also decided this week to move ahead with mass vaccination of children aged 12-15, which the NHS said would begin in schools next week.

France suspends 3,000 health staff as Europe targets vaccine refusal

PARIS (Reuters) – Hospitals, care homes and health centres have suspended around 3,000 workers across France for failing to comply with mandatory COVID vaccination, the government said on Thursday, as countries around Europe weigh how far to go to combat the pandemic https://www.reuters.com/world/europe/european-nations-plans-coping-with-covid-19-2021-09-15. While Italy is set to announce later on Thursday that proof of vaccination or a negative test will be compulsory for all workers, going further than any other country in the region, the Netherlands plans a similar step – but only to go to bars or clubs https://www.reuters.com/world/europe/dutch-expected-ease-covid-19-measures-introduce-corona-pass-2021-09-14. Britain, meanwhile, says it is highly likely to require front-line health and social care workers in England to be vaccinated as part of a plan https://www.reuters.com/business/healthcare-pharmaceuticals/uk-likely-require-health-workers-be-vaccinated-against-covid-2021-09-14 to contain the virus during winter. In France, President Emmanuel Macron’s decision in mid-July to require a similar health pass to go anywhere from restaurants to gyms and museums, and make the jab mandatory for health workers, has massively increased vaccination take-up. With the mandate for workers in hospitals and care homes taking effect on Wednesday, its very concrete impact – unvaccinated staff forbidden to work – started to be felt https://www.reuters.com/world/europe/french-hospital-worker-im-hunger-strike-over-vaccine-mandate-2021-09-16. According to local daily Nice Matin, nearly 450 health workers – out of 7,500 – have been suspended in just one hospital in the city of Nice, in southern France. The government, however, shrugged off the impact. “It hasn’t been chaos, far from it,” Health Minister Olivier Veran told French RTL radio, adding there were 27 million workers in the sector. There have been a few cases where it has affected care, he said, like the use of an MRI being briefly complicated, but most suspended staff work in support roles, limiting the impact. “Most of the suspensions are only temporary … many have decided to get vaccinated as they see that the vaccination mandate is a reality,” Veran said. But unions warn of likely disruptions to care, and just a few absentees in a team is enough to trigger a crisis, Emmanuel Chignon, a care home manager in Bordeaux told Reuters this week, pointing to how hard it was to hire staff https://www.reuters.com/business/healthcare-pharmaceuticals/french-care-home-some-staff-quit-over-vaccine-mandate-2021-09-15 in the sector. “If we can’t replace the carers who leave, the work will fall on the others, and I fear an unvirtuous circle, with tiredness, exhaustion and an increase in absenteeism,” he said. In Italy, where vaccination for health workers was made mandatory at the end of March, some have been suspended, but with numbers nowhere near those seen in France. As of Sept. 16, some 728 doctors in all of Italy had been suspended for failing to be vaccinated, the Italian doctors’ federation said. Italy is now set to go much further and announce on Thursday that a “Green pass” – showing someone has received at least one vaccine dose, tested negative or recently recovered from the virus – will be mandatory for all public and private sector workers. Failure to have a Green Pass will result in workers being suspended and losing their pay. In other countries, like the Netherlands, opinion polls show a majority of the public favouring mandatory vaccination for health workers, with the workers themselves mostly opposed to it, and the government has said it will not take such measures. However a pass showing proof of vaccination or a recent negative coronavirus test is set to be required there as of Sept 25 to go to bars, restaurants, clubs or cultural events. Although polls have shown that a majority of the Dutch support the measure, the pass is strongly opposed by the around 30% of the population who have so far refused to be vaccinated. Critics say the measure is meant to force people to get the jab.

Beijing, China — China has fully vaccinated more than one billion people against the coronavirus — 71 percent of its population — official figures showed Thursday. The country had mostly curbed the virus within its borders but is racing to get the vast majority of its population vaccinated as a new outbreak takes hold in the southeast. “As of September 15, 2.16 billion vaccine doses have been administered nationwide,” said National Health Commission spokesman Mi Feng at a press briefing. Chinese health authorities said late last month that 890 million people in China had been fully vaccinated and two billion doses administered. The government has not publicly announced a target for vaccination coverage, but top virologist Zhong Nanshan said last month that the country is likely to have 80 percent of its population inoculated by the end of the year. China is currently battling an outbreak of the Delta variant in the southeastern province of Fujian that has infected almost 200 people so far in three cities, many of whom are schoolchildren. The Fujian cluster is the biggest rebound in weeks and comes after the country declared the Delta variant under control, in a test of China’s “zero-case” approach to the pandemic. China reported 80 new cases on Thursday, of which 49 were domestic transmissions.

WASHINGTON — White House coronavirus response coordinator Jeff Zients said Wednesday the United States is a developing a “new system for international travel” that will include new strong mitigation procedures like contact tracing. the administration does not plan to immediately relax any travel restrictions because of COVID-19 Delta variant cases. “We are exploring considering vaccination requirements for foreign nationals traveling to the United States,” Zients said. Coronavirus response coordinator Jeff Zients said Wednesday the United States is a developing a “new system for international travel” that will include new strong mitigation procedures like contact tracing. Zients told the U.S. Travel and Tourism Advisory Board Wednesday the administration does not plan to immediately relax any travel restrictions because of COVID-19 Delta variant cases. “We are exploring considering vaccination requirements for foreign nationals traveling to the United States,” Zients said. he idea was shelved, but top White House officials say that proposal and similar ones are still under consideration – including, potentially, a broader vaccine mandate that would include domestic air travel. “We’re discussing it,” Anthony Fauci, President Joe Biden’s chief medical adviser, said about the idea of a broader requirement in an interview. “It’s on the table for discussion.”

A third dose of the Pfizer-BioNTech COVID-19 vaccine could offer strong protection against the Indian ‘Delta’ variant, data reveals, as a separate study finds protection provided by the vaccine could wane after six months. New data released by the company on Wednesday showed antibody levels increased five-fold among people ages 18 to 55 who were given the booster shot. The third dose was especially effecting for the elderly, with antibody levels spiking 11-fold among people aged 65 to 85 who had already received the standard two doses. In the slides published online, the researchers wrote there there is ‘estimated potential for up to 100-fold increase in Delta neutralization post-dose three compared to pre-dose three.’

 

Data from Pfizer shows that the third dose of the company’s COVID vaccine can increase antibodies to fight the Delta variant 11-fold in people 65 to 85 The Delta variant continues to spread across the country, making up at least 83 percent of all new infections. Pfizer produces the most commonly used vaccine in the U.S., having been administered over 190 million times, according to data from the Centers for Disease Control and Prevention (CDC). Early adopters of the vaccine may soon has their immunity to the virus slightly diminished. Research, which has not been peer-reviewed, led by Pfizer and Syracuse University in New York finds that the vaccine was 91 percent effective in preventing the virus for six months. It continues to drop at that rate, researchers say, the vaccine could drop below 50 percent efficacy 18 months after administration. Those who received the vaccine first may have already had its efficacy drop, meaning a third dose could be required soon.

Proof NIH funded Wuhan Covid19 Experiments